International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use - PDFSEARCH.IO - Document Search Engine

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
Results: 311

#	Item
261	Guidance for Industry E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of Qualification Add to Reading List Source URL: www.fda.gov Language: English Clinical research Pharmacology Drug discovery Pharmaceutical industry Clinical Data Management Biomarker Electronic Common Technical Document Proteomics International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Medicine Biology Research
262	Microsoft Word - 9621fnl.doc Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical industry Clinical research Pharmaceuticals policy Food and Drug Administration Quality Validation International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Center for Biologics Evaluation and Research Good manufacturing practice Medicine Health Pharmaceutical sciences
263	Microsoft Word - 9391fnl.doc Add to Reading List Source URL: www.fda.gov Language: English Food and Drug Administration Clinical research Pharmaceuticals policy Drug safety United States Public Health Service International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Center for Biologics Evaluation and Research Pharmacopoeia Capillary electrophoresis Medicine Health Pharmaceutical sciences
264	Microsoft Word - 8671fnl.DOC Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Pharmacology Clinical research Pharmacopoeias Pharmaceuticals policy International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Center for Biologics Evaluation and Research Biologic Center for Drug Evaluation and Research Food and Drug Administration Medicine Health
265	Guidance for Industry Q1C Stability Testing for New Dosage Forms ICH November 1996 Add to Reading List Source URL: www.fda.gov Language: English Food and Drug Administration Dosage forms Clinical research Drug safety Center for Biologics Evaluation and Research Biologic International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Center for Drug Evaluation and Research Tablet Pharmaceutical sciences Pharmacology Medicine
266	Microsoft Word - 9116fnl.doc Add to Reading List Source URL: www.fda.gov Language: English Food and Drug Administration Clinical research Pharmaceuticals policy Drug safety Therapeutics International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Center for Biologics Evaluation and Research Pharmacopoeia Health Canada Medicine Health Pharmaceutical sciences
267	Guidance for Industry M4S: August 2001 ICH Add to Reading List Source URL: www.fda.gov Language: English Clinical Data Management Food and Drug Administration Pharmacology Common Technical Document International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Clinical trial Electronic Common Technical Document Center for Biologics Evaluation and Research Research Clinical research Medicine
268	Guidance for Industry M4Q: The CTD-Quality August 2001 Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical industry Pharmacology Clinical Data Management Medical informatics Common Technical Document Food and Drug Administration International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Validation Package insert Clinical research Research Pharmaceutical sciences
269	Guidance for Industry M4: The CTD - General Questions and Answers Add to Reading List Source URL: www.fda.gov Language: English Medicine Food and Drug Administration Pharmaceutical industry Health Drug safety Electronic Common Technical Document Common Technical Document International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Marketing authorization Clinical research Research Clinical Data Management
270	Microsoft Word - 7042fnl.doc Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Pharmacology Electronic Common Technical Document Drug safety Common Technical Document HTML element International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use HTML Food and Drug Administration Research Clinical research Clinical Data Management